NRM-823 for advanced or metastatic refractory solid tumors
A Phase 1a/1b Study of NRM-823 as Monotherapy and in Combination With Immune Checkpoint Inhibition in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
This trial tests whether NRM-823 is safe and can help people with advanced or metastatic head and neck, esophageal, gastric, or related cancers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Normunity AccelCo, Inc. Industry-sponsored |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 9 sites (Denver, Colorado and 8 other locations) |
| Trial ID | NCT07182149 on ClinicalTrials.gov |
What this trial studies
NRM-823 is being studied in a Phase 1 dose-escalation and expansion format for adults with locally advanced or metastatic refractory solid tumors, focusing on head and neck, esophageal, gastric, and GEJ cancers. Part A uses escalating doses to define safety, tolerability, and a recommended dose, Part B enrolls an expansion cohort at that dose to better characterize safety and early activity, and Part C explores adding a checkpoint inhibitor to the drug to assess combination tolerability. Eligible participants need ECOG 0-1 and adequate organ and marrow function and must meet specified washout periods from prior therapies. The primary objectives are safety and tolerability with exploratory evaluation of anti-tumor signals, conducted at Normunity investigational sites in the United States.
Who should consider this trial
Good fit: Ideal candidates are adults with histologically confirmed locally advanced or metastatic HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma (or other eligible solid tumors listed in the protocol) who have ECOG 0-1 and adequate organ and marrow function and meet protocol washout requirements.
Not a fit: Patients with poor performance status (ECOG >1), significant organ dysfunction, recent anticancer therapy within specified washout windows, or prior high-grade pneumonitis are unlikely to benefit from or be eligible for this trial.
Why it matters
Potential benefit: If successful, NRM-823 could become a new treatment option that controls tumor growth for patients with refractory head and neck and upper gastrointestinal cancers.
How similar studies have performed: While combining novel targeted agents with checkpoint inhibitors has shown benefit in some cancers, NRM-823 itself is at first-in-human/Phase 1 stages with limited prior clinical data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Have histologically- or cytologically-diagnosed NSCLC (squamous or adenocarcinoma), TNBC, HNSCC, ESCC, esophageal adenocarcinoma, gastric/GEJ adenocarcinoma, cervical, endometrial, or ovarian cancer which is advanced or metastatic. * Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. * Adequate liver, renal, pulmonary, and cardiac function. * Adequate hematologic function. Exclusion Criteria: * Has received cytotoxic chemotherapy, biologic anticancer agents, checkpoint inhibitors, or radiation therapy (excluding bone-only radiation therapy) ≤3 weeks or 5 half-lives (whichever is shorter) prior to the first dose of NRM-823 * History of Grade 2 pneumonitis requiring steroids or any Grade 3 or 4 pneumonitis from any prior therapy. * Has received an investigational therapy \<4 weeks or 5 half-lives prior to the first dose of NRM823, whichever is shorter prior to the first dose of NRM-823. * With the exception of alopecia and Grade ≤2 neuropathy, any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study drug.
Where this trial is running
Denver, Colorado and 8 other locations
- Normunity Investigational Site — Denver, Colorado, United States (Recruiting)
- Normunity Investigational Site — New Haven, Connecticut, United States (Recruiting)
- Normunity Investigational Site — Minneapolis, Minnesota, United States (Recruiting)
- Normunity Investigational Site — Maumee, Ohio, United States (Recruiting)
- Normunity Investigational Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Normunity Investigational Site — Nashville, Tennessee, United States (Recruiting)
- Normunity Investigational Site — Dallas, Texas, United States (Recruiting)
- Normunity Investigational Site — San Antonio, Texas, United States (Recruiting)
- Normunity Investigational Site — Fairfax, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Judy Schnyder, MBA
- Email: judy.schnyder@normunity.com
- Phone: 215-593-7119
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.